RUT vs. Molecular Testing for H. Pylori

NCT06684860 | Completed

• 1 other identifier: SCH-HP-2024-12
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The rapid urease test (RUT) is frequently performed for diagnosis of Helicobacter pylori infection in clinical practice. The RUT is a simple and inexpensive method that utilizes a commercial kit containing urea and a pH indicator such as phenol red. In the presence of H. pylori urease, urea is hydrolyzed to ammonia, which raises the pH of the medium, and changes the color of the kit from yellow to magenta or pink. The sensitivity and specificity of RUT were reported to range between 80-100% and 97-99%, respectively. When endoscopy is performed, RUT is known as the first-line method used for H. pylori diagnosis. However, RUT is an indirect test method, and has the disadvantage of causing false positivity due to other urease-producing bacteria. To date, gold standards for H. pylori diagnosis are culture and histological examination Because H. pylori is a rather fastidious and slow-growing bacterium, antimicrobial susceptibility testing using culture methods is time-consuming (10-14 days) and requires specific expertise. Recently, dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection. Moreover, molecular testing can identify point mutations related to clarithromycin resistance. It can be performed in a standard thermocycler and takes only 4 h to complete. The concordance rate between conventional clarithromycin susceptibility testing and DPO-PCR was excellent up to 95%. However, there was no comparison study between RUT and molecular testing for H. pylori diagnosis.

Conditions

H.Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Current H. pylori infection status

  RUT or molecular testing

  1 day

Study Arms (2)

RUT group

The rapid urease test (RUT) was performed for diagnosis of H. pylori infection.

Molecular test group

DPO-PCR testing was performed for diagnosis of H. pylori infection.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

H. pylori-infected patients

You may qualify if:

• Gastroscopy can be performed
• H. pylori test and pathological analysis can be performed

You may not qualify if:

• Age \< 20 or \> 80 years
• Anemia (serum hemoglobin level \< 10 g/dL)
• Severe systemic disease
• Advanced chronic liver disease
• Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
• History of H. pylori eradication
• Drug allergy to antibiotics
• History of gastric surgery
• Recent history of upper gastrointestinal bleeding

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

Location

Study Officials

• Jun-Hyung Cho, M.D.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)